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NDC 70000-0098-01 Leader 4 g/100g Details

Leader 4 g/100g

Leader is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Cardinal Health. The primary component is LIDOCAINE HYDROCHLORIDE.

Product Information

NDC	70000-0098
Product ID	70000-0098_cea6bd2d-a266-1209-e053-2995a90ab0a5
Associated GPIs
GCN Sequence Number	075061
GCN Sequence Number Description	lidocaine HCl CREAM (G) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	39982
HICL Sequence Number	001478
HICL Sequence Number Description	LIDOCAINE HCL
Brand/Generic	Generic
Proprietary Name	Leader
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine HCL
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	4
Active Ingredient Units	g/100g
Substance Name	LIDOCAINE HYDROCHLORIDE
Labeler Name	Cardinal Health
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 70000-0098-01 (70000009801)

Pricing Information
NDC Package Code	70000-0098-1
Billing NDC	70000009801
Package	1 BOTTLE, PLASTIC in 1 CARTON (70000-0098-1) / 76.5 g in 1 BOTTLE, PLASTIC
Marketing Start Date	2021-10-18
NDC Exclude Flag	N
Price Per Unit	0.0479
Pricing Unit	GM
Effective Date	2024-02-21
NDC Description	LIDOCAINE HCL 4% CREAM
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL cea6bd2d-a265-1209-e053-2995a90ab0a5 Details

Active ingredient

Lidocaine HCl 4%

Purpose

Topical analgesic

Uses

temporarily relieves pain and itching due to:

minor burns
sunburn
minor cuts
scrapes
insect bites
minor skin irritations

Warnings

For external use only

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product do not get into eyes

Stop use and ask a doctor if

condition gets worse
symptoms last for more than 7 days
symptoms clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily
children under 2 years: ask a doctor

Other information

store between 20 °C and 25 °C (68 °F and 77 °F)

Inactive ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,

C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

Principal display panel

Leader

NDC 70000-0098-1

Maximum Strength

Lidocaine

Pain Relief

Cream

Lidocaine HCl 4% Topical Analgesic

Non Greasy

Compare to aspercreme lidocaine cream

active ingredient

100% Money Back Guarantee

Net wt 2.7 oz (76.5g)

INGREDIENTS AND APPEARANCE

LEADER

lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70000-0098
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
CETETH-20 PHOSPHATE (UNII: 921FTA1500)
STEARETH-21 (UNII: 53J3F32P58)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70000-0098-1	1 in 1 CARTON	10/18/2021
1		76.5 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/18/2021

Labeler - Cardinal Health (063997360)

Registrant - Weeks & Leo Company Inc (005290028)

Name	Address	ID/FEI	Business Operations
Establishment
Weeks & Leo Company Inc		005290028	manufacture(70000-0098)

Revised: 10/2021

Document Id: cea6bd2d-a266-1209-e053-2995a90ab0a5

Set id: cea6bd2d-a265-1209-e053-2995a90ab0a5

Version: 1

Effective Time: 20211018